U.S. patent application number 13/827707 was filed with the patent office on 2013-12-12 for sealed infusion device with electrical connector port.
This patent application is currently assigned to Tandem Diabetes Care, Inc.. The applicant listed for this patent is Tandem Diabetes Care, Inc.. Invention is credited to Anthony Barghini, Justin Brown, Robert Eastridge, Marcus Julian, Philip Lamb, Donald Ludolph, Michael Michaud, Michael Roisinko, Sean Saint.
Application Number | 20130331790 13/827707 |
Document ID | / |
Family ID | 49712582 |
Filed Date | 2013-12-12 |
United States Patent
Application |
20130331790 |
Kind Code |
A1 |
Brown; Justin ; et
al. |
December 12, 2013 |
SEALED INFUSION DEVICE WITH ELECTRICAL CONNECTOR PORT
Abstract
A portable medical device includes an interface for accepting, a
power supply and enabling data transfer while still connected to a
human body. The interface may include a universal serial bus
interface and may be coupled to a data isolation chip and a power
isolation chip. A power controlling processor may determine how the
supplied power, e.g., voltage, is supplied to other components
within the infusion device. Additional circuitry within the system
may provide a secure power transfer within the device to ensure
user safety and ensure that a high frequency noise is properly
attenuated.
Inventors: |
Brown; Justin; (San Diego,
CA) ; Ludolph; Donald; (San Diego, CA) ; Lamb;
Philip; (San Diego, CA) ; Barghini; Anthony;
(San Diego, CA) ; Saint; Sean; (San Diego, CA)
; Julian; Marcus; (San Diego, CA) ; Eastridge;
Robert; (San Diego, CA) ; Roisinko; Michael;
(Anaheim, CA) ; Michaud; Michael; (San Diego,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Tandem Diabetes Care, Inc. |
San Diego |
CA |
US |
|
|
Assignee: |
Tandem Diabetes Care, Inc.
San Diego
CA
|
Family ID: |
49712582 |
Appl. No.: |
13/827707 |
Filed: |
March 14, 2013 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61656967 |
Jun 7, 2012 |
|
|
|
Current U.S.
Class: |
604/151 |
Current CPC
Class: |
A61M 5/14 20130101; A61M
2205/505 20130101; A61M 5/14244 20130101; A61M 5/142 20130101; A61M
2205/3569 20130101; A61M 2205/8206 20130101; H01R 13/5213 20130101;
A61M 2205/3584 20130101; H01R 13/5224 20130101; H01R 13/447
20130101; A61M 2205/8262 20130101; A61M 2039/1022 20130101; A61M
2205/8237 20130101; A61M 39/10 20130101 |
Class at
Publication: |
604/151 |
International
Class: |
A61M 5/142 20060101
A61M005/142 |
Claims
1. An ambulatory infusion pump, comprising: a housing having a
front surface and a back surface that are spaced apart and enclosed
by side surfaces to define an internal cavity; an electrical
connector port fitted to the housing and extending into the
internal cavity, the electrical connector port operably connected
to a power isolation connector and a data isolation connector
disposed within the housing, the electrical connector port adapted
to receive electrical power and data and direct the electrical
power to the power isolation connector and the data to the data
isolation connector; and wherein the housing and electrical
connector port provide a seal preventing passage of moisture into
the internal cavity.
2. The ambulatory infusion pump of claim 1, further comprising an
electrical connector port door configured to be attached to the
housing over the electrical connector port.
3. The ambulatory infusion pump of claim 2, wherein a seal is
formed between the electrical connector port and the electrical
connector port door.
4. The ambulatory infusion pump of claim 3, further comprising an
overmold formed around the power isolation connector and in contact
with the electrical connector port that provides the seal between
the electrical connector port and the electrical connector port
door.
5. The ambulatory infusion pump of claim 4, wherein the overmold is
comprised of a non-conductive material.
6. The ambulatory infusion pump of claim 1, wherein the power
isolation connector is electrically isolated from the data
isolation connector.
7. The ambulatory infusion pump of claim 1, wherein the power
isolation connector includes a transformer capable of producing a
substantially constant output.
8. The ambulatory infusion pump of claim 1, further comprising: a
processor disposed in the housing; and a touch sensitive display
screen, wherein the processor is capable of receiving inputs from
the touch sensitive display screen.
9. The ambulatory infusion pump of claim 1, wherein the power
isolation connector is coupled to a power isolation circuit, and
wherein the power isolation circuit includes a transformer capable
of outputting a substantially constant output.
10. An ambulatory infusion pump, comprising: a housing define an
enclosed internal cavity; an electrical connector port fitted to
the housing and extending into the internal cavity, the electrical
connector port including an opening adapted to receive electrical
power and data through a common connection; a connector power
element operably connected to the electrical connector port to
receive the electrical power; a connector data element operably
connected to the electrical connector port to receive the data; and
an overmold disposed within the housing, the overmold enclosing the
electrical connector port, the connector power element, and the
connector data element, to electrically isolate the electrical
connector port, the connector power element, and the connector data
element from the internal cavity of the housing.
11. The ambulatory infusion pump of claim 10, wherein the
electrical connector port opening is exteriorly exposed on the
housing, and further comprising an electrical connector port door
configured to be attached to the housing over the electrical
connector port.
12. The ambulatory infusion pump of claim 11, further comprising an
o-ring providing a seal between the housing and the electrical
connector port door.
13. The ambulatory infusion pump of claim 12, further comprising an
o-ring providing a seal between the electrical connector port and
the housing.
14. The ambulatory infusion pump of claim 10, wherein the overmold
is comprised of a non-conductive material.
15. The ambulatory infusion pump of claim 10, wherein the connector
power element is electrically isolated from the connector data
element.
Description
RELATED APPLICATION
[0001] The present application claims the benefit of U.S.
Provisional Application No. 61/656,967 filed Jun. 7, 2012, which is
incorporated herein in its entirety by reference.
BACKGROUND
[0002] Electrically-powered portable devices often include portable
power sources, such as batteries, that must be recharged
periodically. Many such devices also provide communications to a
host device or other associated machinery, so as to exchange data
relating to device operation, maintenance history, and the like.
Recharging a portable device and exchanging data through a host
device, which provides a power source, often involves receiving
electrical power and communicating data over a single connection.
Such connections may comprise, for example, a Universal Serial Bus
(USB) connector coupling the portable device to a host computer or
a USB hub. The portable device often must be constructed for
operation so it is isolated from the source that provides
electrical power for operation and for charging, and often must be
isolated as well from the source of data exchange and
communications. Such portable devices may include laboratory
devices, portable test equipment, and portable user devices.
[0003] One example of a portable device such as described above is
a device that involves the delivery of fluids. There are many
applications in academic, industrial, and medical fields, as well
as others, that involve devices capable of accurately and
controllably delivering fluids, including liquids and gases, that
have a beneficial effect when administered in known and controlled
quantities. This is particularly true in the medical field, where
treatments for many patients include the administration of a known
amount of a substance at predetermined intervals. For example, the
treatment of diabetes involves just such a regimented dosage of
medicaments such as insulin. In addition, diabetes is one of a few
medical indications wherein the patient routinely administers the
medicament (such as insulin) to themselves by a subcutaneous
modality, such as, e.g., via a hypodermic syringe injection or an
ambulatory infusion device, or pump. This is an example wherein
providing a patient with the safe, reliable, and comfortable
administration of required doses of medication may be particularly
important in order to facilitate patient compliance and accurate
treatment of the condition. In view of the human involvement,
government regulations and industry standards often impose
requirements for control of electromagnetic emissions, power
leakage, and the like.
[0004] Ambulatory insulin infusion pumps have been developed for
the administration of medicaments such as insulin for those
diagnosed with both type I and type II diabetes. These pumps offer
an alternative to multiple daily injections of insulin by an
insulin syringe or an insulin pen. They also allow for continuous
insulin therapy. In addition, some ambulatory infusion devices can
include data collection and storage mechanisms, which allow a
diabetic patient/user and/or a caregiver (e.g., doctor, health care
worker, family member, and so forth) to easily monitor and adjust
insulin intake. The infusion device may be powered by a
rechargeable battery that requires periodic recharging.
[0005] For safety, the user of a medical infusion device must be
isolated from electrical hazards when handling the portable medical
device during recharging. A "user" refers to a person who is
operating the medical infusion device, and may comprise a patient,
diabetic person, caregiver, and the like. Additionally, the user
must be isolated from electrical hazards during everyday use. Such
use can result in exposure to water and other liquids, e.g., sweat,
which may come into contact with the device. When a conventional
device becomes wet, the device can malfunction or shut down
completely, or might produce an electrical shock to the user of the
device. Accordingly, it is also desirable to protect the device in
the case that it is exposed to water and liquids, so that the
device is still capable of delivering insulin to the patient and
maintaining data necessary for operation, while also preventing any
bodily harm to the user and/or to the patient. As used herein, the
term "user" will be understood to include a person who is a
patient, and may include other persons such as caregivers,
clinicians, certified diabetes instructors (CDEs), medical
professionals, and the like, depending on the context in which
"user" is mentioned.
[0006] There is a need for a portable device that safely
facilitates user interaction, data collection, and recharging while
providing electrical and data isolation. In this way, it is not
necessary for the portable device to be removed from a patient
while connecting the device to a power source or data
communications host.
SUMMARY
[0007] As disclosed herein, a portable device includes a housing
having a front surface and back surface that are spaced apart and
enclosed by side surfaces to define an internal cavity, and an
electrical connector port that is fitted to the housing and extends
into the internal cavity. The electrical connector port receives
electrical power and data such that the electrical connector port
directs the electrical power to a power isolation connector and
directs the data to a data isolation connector. The housing and
electrical connector port are configured to provide a seal that
prevents the passage of moisture into the internal cavity. In one
embodiment, the seal is formed between the electrical connector
port and the electrical connector port door with an over-mold that
prevents the passage of moisture into the internal cavity. The
portable device provides electrical and data isolation and also
prevents the passage of moisture into the internal cavity.
[0008] In other aspects, disclosed herein is a portable medical
device which is capable of being coupled to a dedicated power
source, e.g., wall outlet, or to a configured power source, e.g.,
personal computer. The infusion device is further designed such
that the connection to either of these sources is available during
use of the device. The infusion device is also designed to
withstand exposure to water and other liquids, which may otherwise
harm the user or alter the functionality of the device.
[0009] Other features and advantages of the present invention will
be apparent from the following description of the embodiments,
which illustrate, by way of example, the principles of the
invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 depicts a portable device according to an embodiment
of the present invention that is coupled to a host device and is
electrically isolated from the host.
[0011] FIG. 2 is a block diagram of circuitry and components for a
portable medical device embodiment with electrical power isolation
and data isolation.
[0012] FIG. 3 is a schematic that depicts the front side of a
portable medical device in an embodiment.
[0013] FIG. 4 is a schematic that depicts the circuitry and
components of a portable medical device with the front side housing
removed as in FIG. 3.
[0014] FIG. 5 is a schematic that depicts the circuitry and
components of a portable medical device with the front side housing
removed as in FIG. 3.
[0015] FIG. 6 is a perspective view of FIG. 5 in which the
cartridge side of the portable medical device is shown in one
embodiment.
[0016] FIG. 7 is a perspective view of FIG. 5 in which a top and
side of the portable medical device are shown in one
embodiment.
[0017] FIG. 8 is a schematic that depicts a cross-sectional view of
the portable medical device in FIG. 5.
[0018] FIG. 9 is a schematic that depicts a top perspective view of
an electrical connector port assembly used in the portable medical
device of FIG. 3 in one embodiment.
[0019] FIG. 10 is a schematic that depicts a bottom view of the
electrical connector port assembly of FIG. 9.
[0020] FIG. 11 is a schematic that depicts the electrical connector
port assembly in FIG. 10 having the overmold removed.
[0021] FIG. 12 is a schematic that depicts a front view of the
electrical connector port and interface in FIG. 10.
[0022] FIG. 13 is a schematic of a back view of a portable medical
device, having the cartridge cover and pump cover removed.
[0023] FIG. 14 is a schematic that depicts a perspective view of
FIG. 13 in one embodiment.
[0024] FIG. 15 is a schematic that depicts an alternative
perspective view of FIG. 13, having the back face of the housing
removed.
[0025] FIG. 16A-16C are schematics of various views of an input
button shown in FIG. 15
[0026] The drawings illustrate embodiments of the technology and
are not limiting. For clarity and ease of illustration, the
drawings may not be made to scale and, in some instances, various
aspects may be shown exaggerated or enlarged to facilitate an
understanding of particular embodiments.
DETAILED DESCRIPTION
[0027] Disclosed herein are embodiments of an electrically-powered
portable device that is periodically recharged and is capable of
operation while also being isolated from a host device from which
it receives power and with which it exchanges data. The portable
device includes components that are physically insulated from
outside elements, such as liquids.
[0028] The aforementioned isolation features of the portable device
are often based on regulations and other requirements to ensure
user safety during use of the portable device. Such requirements
vary for different portable devices and, in particular, for
portable medical devices that provide a more critical function to a
patient. For example, isolation from the electrical current
provided during charging of the device ensures that the user will
not incur an electrical shock during use and details of the
isolation are often specified by government regulations or by
safety licensing bodies. The isolation from outside elements allows
the device to continually function. For example, the isolation
ensures that the device wall not suffer a short circuit from water
damage, ensuring proper insulin delivery to a user and preventing
electrical shock to the user. Not only may isolation of certain
elements within the device be necessary for regulatory compliance,
it also may be important to meet electrical requirements of the
device elements. For example, proximity of components to the
housing and between other electrical components can cause
capacitance issues and voltage hazards for the user. Furthermore,
emissions from the various components within, the portable device
should be controlled to minimal levels to be within a safe
operating range for a patient. Various regulatory standards are
further discussed in the following description of the portable
medical device of the present invention.
[0029] FIG. 1 shows an electrically-powered portable device 100
that is coupled to a host power source 102, such as a desktop or
laptop computer, through a cable 104. The cable may comprise, for
example, a coupling through which both data and electrical energy
are received at the portable device 100. Examples of such combined
power and data cables include a Universal Serial Bus (USB)
connection, an IEEE 1499 connection, a "THUNDERBOLT" connection
(i.e., from Apple, Inc, of Cupertino, Calif., USA), PCI Express,
eSATA and Ethernet. The host power source 102 is a source of
electrical energy and can be any type of computing device that
includes a port 106 that receives a connector 108 of the cable 104.
The port of the host computing device may comprise, for example, a
USB port, or IEEE 1499 port, or port for THUNDERBOLT, PCI Express,
eSATA or Ethernet. A compatible connector port 110 of the portable
device 100 is coupled to the cable 104 at an opposite end 112 of
the cable. In a USB implementation, for example, the cable 104 is a
USB cable and associated connections and ports may support one or
more of USB version 1.1, 2.0, or 3.0 data transfer speeds.
[0030] The portable device 100 may be coupled to a patient 114 via
an infusion port 116 and a connecting tube or cannula 118. The
connecting tube is coupled to the portable device 100 at a fluid
dispensing port 120. The portable device may include control
features, such as buttons or switches 121 to receive user input and
control pumping and the like, and may include a display screen 122
on which messages and alerts are displayed. The display 122 may
comprise, for example, a touchscreen on which user inputs may be
received. A housing 124 of the portable device encloses internal
components, such as fluid reservoirs, electrical components,
battery, and the like. The portable device 100 illustrated in FIG.
1 comprises a portable medical device of the type worn by a patient
114 such that insulin or other fluid is delivered via the
connecting tube 118 and the fluid dispensing port 120. Exemplary
ambulatory medical devices and features include those, e.g.,
disclosed in U.S. patent application Ser. No. 13/557,163, U.S.
patent application Ser. No. 12/714,299, U.S. patent application
Ser. No. 12/538,018, U.S. Provisional Patent Application No.
61/655,883, U.S. Provisional Patent Application No. 61/656,967 and
U.S. Pat. No. 8,287,495. Each of the aforementioned documents is
hereby incorporated herein by reference in its entirety.
[0031] With such combined power and data connections, data may be
exchanged between the portable medical device 100 and the host
power source 102 over the cable 104, and the portable device 100
may also receive electrical power from the host power source over
the cable. As described further below, the portable device 100
incorporates an electrical isolation feature in which the circuitry
within the portable device for both data and power is electrically
isolated from the power source 102. Additionally, the electrical
isolation feature within the portable device 100 allows for
circuitry within the device to be protected from outside elements,
with which the device may come into contact with during normal
every day operation. The operation of the portable device is also
controlled so as to reduce radio frequency (RF) emissions. In all
of the aforementioned embodiments, because of the isolation feature
of the portable device 100, the connection of the portable device
to a patient 114 may be maintained even as the device is connected
and disconnected from the source computer 102, and even as the
device is exposed to liquids, such as water, without fear of
electrical shock or undue RF emissions to the patient 114.
[0032] The portable medical device 100 of FIG. 1 is designed to
operate such that radio frequency (RF) and electromagnetic field
(EMF) emissions from the portable device are maintained at safe
levels for close human interaction throughout operation of the
device, including operating states such as a charging state, power
up state, inactive state, e.g., shelf or suspend mode, and active
state, such as when all components fully functional. EMF emissions
from portable devices are regulated to require such emissions to be
within specified levels in order to be considered acceptably
safe.
[0033] Those skilled In the art will understand that a combined
data/power connection such as USB, IEEE 1499, THUNDERBOLT, PCI
Express, eSATA, and the like must be configured for power delivery
before full utilization for recharging of the connected portable
device is possible. That is, upon initial coupling of a portable
device to a combined data/power connection of a host computer
device, only a reduced current flow is available. After
communication between the device and the host computer through a
connection port has been completed and the connection has been
properly configured, then a greater amount of current is available
to the device that is sufficient for device operation as well as
battery recharging. In further embodiments, the power cable
connector 104 may be connected to a power source 101 that is a
dedicated power supply (without data exchange capabilities)
connected to a source such as a conventional wall outlet, car power
outlet (e.g., cigarette lighter connection), or other power-only
source. For example, the power source 101 may comprise a power
converter that receives a line AC voltage and produces a DC output
voltage at a predetermined voltage level. The aforementioned type
of power supply will be referred to herein as a dedicated power
source or dedicated power supply. In the case of a dedicated power
source, no configuration is necessary to draw full recharging power
from the power source, and the available source current is not
dependent on configuration, i.e., the dedicated power source is
considered a high voltage source upon connection to the portable
device 100.
[0034] FIG. 2 shows a block diagram of the components within the
portable device 100 of FIG. 1. The portable device 100 includes a
power management system that is connected to the connector port 110
that receives a combined data/power cable, such as the USB cable
104 illustrated in FIG. 1. That is, the cable 104 has the
capability of simultaneously providing electrical energy for
charging and data transmission for communications. A connector
interface 206 supports data exchange and receives electrical power
through the connector port 110, and controls a connector data
element 208 and a connector power element 210. The device may be
powered by battery power in place of or in addition to the
connector interface. The connector interface 206 passes data
communications from the connector port 110 through the connector
data element 208 to a system bus 212. The connector interface 206
passes electrical power from the connector port 110 through the
connector power element 210 to a battery charger 214, which in turn
is coupled to a battery 216 and which recharges the battery. In one
embodiment, the connector data element 208 is implemented in the
FIG. 2 device with a USB Isolation Chip ADUM4160 product from
Analog. Devices, Inc. of Norwood, Mass., USA, and the connector
power element 210 is implemented in the FIG. 2 device with a USB
Power Isolation Chip LT3573 product from linear Technology
Corporation of Milpitas, Calif., USA. Those skilled in the art will
be aware of alternative suitable devices.
[0035] A control processor 218 is connected to the system bus 212
and receives the data communications from the connector data
element 208 for processing. The control processor controls
operation of the various elements of the portable device 100 that
are connected to the system bus. The control processor operates
according to program instructions that may be stored in device
memory 220. Program instructions may be stored in processor memory
incorporated in the control processor 218. The control processor
also stores data from its operations in the device memory 220. The
control processor 218 controls a data communications element 222
that may comprise a receiver/transmitter for wireless RF
communications, such as "WiFi" communications or "Bluetooth"
communications between the portable device 100 and compatible
external systems and networks. The device 100 includes an
output/display element 224 such as a touchscreen display, operating
buttons or switches, and the like. The device 100 of FIG. 1
comprises an infusion, pump device, and therefore also includes a
drive/pump element 226 such as a pumping mechanism for delivery of
fluid such as insulin to the connecting tube 118, as described
above in connection with FIG. 1. To meet industry standards and
governmental regulations, the connector data element 208 and the
connector power element 210 are both electrically isolated from the
other device components, so as to provide a device that can be
safely connected to the power source and the patient at the same
time.
[0036] The memory 220 of the device 100 may be any type of memory
capable of storing data and retrieving that data for transfer to
one or more other components of the device, such as the control
processor 218. The memory may comprise one or more of a Flash
memory, SRAM, ROM, DRAM, RAM, EPROM or dynamic storage. For the
illustrated portable fluid delivery device 100 of FIG. 1, the
device memory 220 may be coupled to the control processor 218 and
may be configured to receive and store input data and/or store one
or more template or predetermined fluid delivery patterns. For
example, the memory can be configured to store one or more
personalized (e.g., user defined) delivery profiles, such as a
profile based on a user's selection and/or grouping of various
input factors; past generated delivery profiles; recommended
delivery profiles; one or more traditional delivery profiles, e.g.,
square wave, dual square wave, basal and bolus rate profiles;
and/or the like. The memory can also store user information,
history of use, glucose measurements, compliance, an accessible
calendar of events, and the like. In some embodiments, the memory
220 of the portable medical device 100 may have a data capacity of
up to about 10 GB, more specifically, up to about 3 GB, even more
specifically, about 1 MB to about 200 MB. In some embodiments, the
memory of the infusion device 200 may be up to about 3 GB, more
specifically, up to about 500 MB, and even more specifically, about
200 kB to about 200 MB.
[0037] FIG. 3 shows a front view of a schematic of a portable
medical device 300, such as the portable device illustrated in FIG.
1, configured as an infusion pump for delivery of insulin to
patients with diabetes. As shown, the device includes a housing 303
having a front face 304. The front face 304 includes an output
display element 301, such as a touchscreen capable of responding to
user interaction "touches" as inputs to control the functionality
of the device. The touchscreen 301 can occupy sufficient surface
area of the front face 304 of the device to facilitate convenient
user interaction with the device.
[0038] The portable medical device 300 includes a housing 303 that
can be of any suitable shape and size to house the device
components. For example, the housing 303 may be extended and
tubular, or in the shape of a square, rectangle, circle, cylinder,
or the like. The housing may be dimensioned so as to be comfortably
associated with a user and/or hidden from view, for example, the
housing may be sized to fit within or beneath the clothes of a user
patient. In some embodiments, the housing 303 of the portable
medical device may have a width of about 2 inches to about 5
inches, a height of about 1 inch to about 3 inches, and a thickness
of about 0.25 inch to about 0.75 inch. More specifically, the
housing 303 may have a width of about 2.5 inches to about 3.5
inches, a height of about 1.5 inches to about 2.5 inches, and a
thickness of about 0.4 inches to about 0.8 inches. For some
embodiments, the housing 303 of the infusion device 300 may have a
width of about 2.5 inches to about 3.5 inches, a height of about 1
inch to about 2 inches and a thickness of about 0.2 inches to about
0.6 inches. The materials of the housing may vary as well. In some
embodiments, the housing 303 may comprise a water-tight, metal
housing that may be opened and disassembled for repairs. In some
embodiments, the housing may be a water-tight, plastic housing.
[0039] As shown in FIG. 3, a door 305 can be located on one side of
the device 300. The door 305 can provide a cover to protect an
interface, e.g., an electrical connector port interface, to which
the device can receive a charger. The door 305 can be located on
any side of the device, dependent on the internal configuration of
the components. In some embodiments, the door 305 can extend from a
first side of the portable medical device housing to a second side
of the housing.
[0040] FIG. 4 illustrates a view of the housing 303 along the outer
edges of the portable medical device 300, including an outer shell
400 and an inner shell 401. The outer shell 400 can be metal, hard
plastic, carbon fiber or another material utilized to externally
protect the device from environmental damages. The inner shell 401
can be utilized to form a seal along the outer shell 400, such that
liquids cannot enter the portable medical device and harm any of
the internal components. The inner shell 401 can be a rubber,
plastic or other polymer material capable of forming an impermeable
seal under pressure.
[0041] FIG. 5 provides a schematic representation of FIG. 3 with
the front face of the housing removed and the internal components
exposed. As shown, the portable medical device 300 can include a
printed circuit board (PCB) assembly including a flex serpentine
board 502, a main board 504, a connector for the flex board and
main board to direct current (DC) 506, a pressure board 503, and a
connector for the ilex board to the pressure board 509.
Additionally, the device includes a Bluetooth PCB assembly 505 for
short wave, such as radio frequency (RF) communication. Such
communication can be useful if a user of the device wishes to
transfer data to, for example, a Bluetooth-enabled mobile
telephone, such as a Smart Phone.
[0042] FIG. 5 shows that the portable medical device 300 also
includes an overmold 501, which thermally and physically separates
the PCB assembly from the connector port interface, utilized for
charging the device. The internal components of the device are all
separated from the outer shell 507 of the housing in order to
prevent any interaction between the internal components and the
housing during use of the device, such as when the device may be
bumped or jostled by the user. The internal components can be
separated by the distance of at least the inner bezel 508,
described with reference to FIG. 4. The internal components can
additionally reside in a cavity created by the outer shell 507,
such that the components do not interact with the front face of the
device, when assembled.
[0043] As previously mentioned, within the housing 303, certain
physical design requirements may also exist which are based on,
e.g., regulatory requirements. For example, the portable medical
device 300 may have include restrictions imposed on the spacing
between other components in the portable medical device and/or the
housing 303 in order to properly insulate each printed circuit
board (PCS) trace as well as the components and the housing of the
device, which can be made of a conductive material. When certain
components are too close to one another within the device,
phenomena such as voltage creepage can occur between each
conductor. Such spacing requirements can influence the design of
the portable medical device, due to the size and number of the
components within the device as well as the voltage drop of those
components within the device.
[0044] In further embodiments, the portable medical device 300
includes isolation and emission control features. Additionally, the
device includes a defined architecture for how electrical power is
delivered to various components of the portable medical device. In
one embodiment, the power is supplied through the electrical
connector port interface (shown in FIGS. 10-11), which supplies
4.65 volts (V) and draws a minimum of 100 mA and a maximum of 500
mA of current, depending on the power source and configuration of
the connection interface. The power is supplied to a, for example,
USB data-isolation integrated circuit (IC) chip 1102 (not
illustrated in FIG. 5; see 1102 shown in FIG. 11) and a USB power
isolation IC chip. The power isolation chip resides below the
overlay 501, which insulates the electrical current from a user of
the device during charging and/or data transfer. Each chip is
capable of receiving the maximum power provided when the device is
connected to a power supply source. The data isolation chip 1102
draws more current than the power isolation chip and includes a
quiescent current that reduces the charge current of the low mode
charging (also referred to as shelf mode or suspend mode) for the
battery (not shown). The battery is charged by a battery charger IC
chip that checks the battery charge level, when the portable
medical device detects that it is connected to a power source. The
output voltage from the USB power isolation chip is coupled to the
battery charger chip to supply electrical charge to the battery.
The output of the battery charger chip, when the infusion device is
connected to a USB power supply source, is coupled to a fuel gauge
(not shown), which determines the current battery charge. The
output of the battery charger is also supplied to the fuel gauge.
The fuel gauge is useful in the case that the portable medical
device is not connected to a USB power source, so that no power
flows through the battery charger chip, because the fuel gauge
permits the battery charge to be known to the system so it may
determine which components should be supplied power during
startup.
[0045] As noted in connection with FIG. 2, control of the device is
provided from a control processor. The control processor may be
provided as a two-element processor, comprising a data control
processor and a power control processor, each part of the main PCB
504. To meet industry standards and government regulations, the
data isolation chip 1102 and the power isolation chip provide
isolation from the other device components so that the chips reduce
EMF emissions and provide a safely functioning device that can be
connected to the power supply source and the patient at the same
time. For example, the data isolation chip 1102 is implemented in
the FIG. 5 device with a USB Isolation Chip ADUM4160 product from
Analog Devices, Inc. of Norwood, Mass. USA, and the power isolation
chip is implemented in the FIG. 5 device with a USB Power Isolation
Chip LT3573 product from Linear Technology Corporation of Milpitas,
Calif., USA. Those skilled in the art will be aware of alternative
suitable devices to provide the data and power charging functions
with isolation.
[0046] Referring to FIG. 6, a perspective view of the portable
medical device 300 in FIG. 3 and FIG. 4 is illustrated in an
embodiment. The portable medical device with electrical power
isolation and data isolation includes a slot 601 for receiving a
replaceable medicament cartridge for, e.g., insulin. The cartridge
slot can be located proximate to one side wall of the device
housing such that the cartridge accessibility and removal is
facilitated. The portable medical device can include an input
button 602 including an outer shell 603 (shown in FIGS. 16A and
16B).
[0047] FIG. 7 is an alternative perspective view of the portable
medical device 300 in one embodiment. As shown, one side wall of
the device housing includes an electrical connector port door 701.
The electrical connector port door 701 includes two parts: a plug
bezel 705 and a flexible joint 706. The flexible joint 706 includes
a plug 1104 (shown in FIG. 11) that is utilized to affix the door
701 to the portable medical device 300. The plug bezel is a movable
portion of the electrical connector port door 701, which is removed
each time that the USB port is utilized. The electrical connector
port door 701 can be made of a rubber or soft polymer, which is
capable of bending, flexing, and maintaining shape without breaking
from continual use. As shown in FIG. 7, the electrical connector
port door 701 is in a closed position.
[0048] The device 300 also includes an input button 700 on one side
wall of the housing of the device, which differs from that of the
electrical connector port. The input button 700 can be any suitable
size or shape that can facilitate providing user input to the
device. In some embodiments, the input button 700 can be utilized
to wake the device from a sleep mode, lock the touchscreen of the
device, and power-off the device. The button 700 can be made of any
material that is capable of withstanding repeated user interaction,
such as a metal, plastic or polymer, or rubber. In order to further
facilitate user interaction with the input button 700, the button
can include a bezel 703, which is illuminated during usage of the
button. The input button is further described in the following
paragraphs with reference to FIGS. 16A-C.
[0049] Still referring to FIG. 7, the cavity created by the housing
of the device is shown as the distance 704 from the top of the
housing wall to the components within the device. As previously
mentioned, this allows for additional protection of the internal
components from contacting the front face of the device during
usage.
[0050] FIG. 8 depicts a cross-sectional perspective view of the
portable medical device 300. The electrical connector port, such as
a USB port 801, is shown with the electrical connector port door
800 in a closed position. As shown, the electrical connector port
door 800 is held in place via an o-ring 810, which itself is held
within grooves 820 of door tabs 822. The door 800 is inserted into
the housing against a door bezel 824, against which the o-ring 810
is compressed and forms a seal. The seal of the o-ring 810 aids in
preventing outside elements and debris from entering into the
device through the internal cavity of the electrical port.
Additionally, the o-ring can aid in securing the door 800 closed.
The o-ring 810 is described in further detail below with reference
to FIG. 10. Also shown In FIG. 8 is a primary o-ring 826, which
provides another seal against the entry of outside elements and the
like.
[0051] FIG. 8 depicts that the overmold 501 previously described
with reference to FIG. 5 includes an upper portion 807 and a lower
portion 802 that are connected together and wrap around the PCB
sides. The overmold portions 807, 802 can vary in thickness along
the surface of the USB interface in order to accommodate various
internal components residing below, such as the DC-to-DC PCB 809,
electrical connector port 801, transformer (not shown in FIG. 8),
and power isolation chip (not shown in FIG. 8). The DC-to-DC PCB
can be flexibly coupled to the main PCB 805 by a flexible PCB 806,
which is also illustrated in FIG. 5. As previously discussed, the
internal components can reside in a cavity formed by the outer
shell 811 of the housing. The housing can also include an inner
shell, which can be compressed to form a seal preventing water
ingress to the portable medical device.
[0052] FIG. 8 also depicts that a crush seal occurs with the
interaction of the bezel 809 pushing the primary o-ring 826 against
an angled sealing surface 828 on the housing. This interaction
compresses or crushes the o-ring into the overmold, creating a seal
at the interface of the bezel, the enclosure, and the overmold.
Sealing due to the overmolding process creates a barrier such that
moisture can't penetrate past the discrete connector on the board
(i.e., the micro-USB connector). Therefore, no leakage can occur
through the micro-USB or passed the interface of the overmold
around it, creating the sealed connector port.
[0053] Referring still to FIG. 8, the input mechanism 803, forming
a connection between the input button (shown in FIG. 7) and the
main PCB 805 is shown. The input button, input mechanism, and
surrounding components are further described with reference to
FIGS. 16A-C in the following paragraphs. The cross-sectional view
in FIG. 8 also shows a rack pushrod 804, which forms the actuator
driving the insulin delivery from the insulin cartridge. The rack
pushrod 804 can be encapsulated by a cover 812 made of flexible
material such as a rubber or soft polymer, which forms a barrier
between the cartridge and the rack mechanism. The pushrod cover 812
can form a barrier, or seal, between the internal components of the
portable medical device, e.g., through the rack mechanism, and the
cartridge in case any accidental leakage occurs within the
cartridge.
[0054] FIG. 9 is a schematic representation of the overmold 501 and
electrical connector port 902 assembly. The overmold 501 may be
shaped according to the power isolation chip and associated
circuitry in order to meet regulatory requirements for a medical
device to prevent any harm incurred by a user of the portable
medical device and prevent any liquid from contacting the
electrical connector input elements of the device. The overmold 501
may be made of an insulator material, which aids in preventing
voltage creepage and emissions from the internal components of the
device. The overmold may be made of a plastic polymer, dielectric,
or other non-conductive material that is capable of being
pre-formed and can maintain its shape during use. The overmold can
be pliable under certain conditions, such as extreme temperatures
in order for molding into the preformed shape to occur. In some
embodiments, the overmold may be a membrane formed on the
components. The overmold 501 is also capable of maintaining shape
and protecting the components over which it is assembled during
temperature changes, e.g., due to dissipation from the circuits.
The overmold can be secured to the PCB board and other internal
device components utilizing screw fasteners, such as screws (not
illustrated) that are threaded into two screw holes 900. The screw
holes may be positioned on the overmold as needed to ensure a seal.
The screw holes 900 guide the screws to pass through the PCB and
into corresponding threaded holes in the housing. In this way, the
screws are electrically isolated from the PCB. The electrical
connector port mouth 902 can be formed with the overmold 501 or as
a separate component from the overmold. The electrical connector
port mouth 902 can be made of a similar non-conductive material as
the overmold that is capable of forming a barrier around the
electrical connector port and capable of securely receiving a
electrical connector plug during charging and data transfer.
[0055] FIG. 10 is a schematic representation of the electrical
connector port and power isolation assembly from a bottom view
perspective. The power isolation assembly includes the electrical
connector port mouth 1005 and the two o-rings 810, 826 described
above in connection with FIG. 8. The o-ring 810 helps secure the
placement of the door within the housing of the portable medical
device and along with the primary o-ring 826 helps to prevent any
outside environmental elements, such as liquids, from entering the
device. The first o-ring 810 can provide a lip onto which an
electrical connector port door (not shown) can securely hinge while
in a closed position. FIG. 10 also illustrates the overmold 1004,
which is formed over the entire power isolation assembly to prevent
any possible electrical shock to a user of the device and to lower
radiation emissions and heat dissipation from the device during
charging. As previously mentioned, the overmold 1004 can be made of
a non-conductive material, such as a plastic polymer, which is
capable of absorbing heat and voltage.
[0056] The power isolation assembly can additionally include a
transformer 1002, which controls the electrical input from the
electrical connector. The transformer 1002 can be customized to
maintain a specified output while receiving variable input currents
from the electrical connector, dependent on the compatibility of
the power supply utilized to charge the device. Accordingly, the
transformer 1002 can have a customized coil turns ratio in the
toroid core, such as approximately 1.33:1, or 12:9, to provide a
more efficient output for the variable input current. The coil
windings can additionally be insulated in order to lower emissions
to meet UL or IEC 60601-1 regulatory standards requirements. In
some embodiments, the windings are double or triple insulated. The
transformer 1002 can include a housing having input leads and
output leads, or pins coupled to the coil wires 1003 utilized to
the secure placement of the transformer 1002 on the PCB and in
order to supply a controlled output to various power isolation
assembly components.
[0057] FIG. 11 illustrates a schematic view of the electrical
connector interlace including the power isolation circuit, which
controls the incoming current and supplies the power to the other
components within the device. As illustrated in FIG. 11, a power
supply can include four output lines that provide power and supply
data from the connector interface with four input points 1107
(shown in FIG. 12) to a data isolation chip 1102 and a power
isolation chip (not shown). Similarly to the previously described
embodiments, the data isolation chip may be implemented in the
portable medical device with a USB Isolation Chip ADUM4160 product
from Analog Devices, Inc. of Norwood, Mass., USA, and the power
isolation chip may be implemented with a USB Power Isolation Chip
LT3573 product from Linear Technology Corporation of Milpitas,
Calif., USA. Those skilled in the art will be aware of alternative
suitable devices to provide the data and power charging functions
with isolation.
[0058] A common mode choke can be coupled to the power supply to
lower RF and EMF emissions and to limit high frequency noise on the
data signal supplied from the power supply. The power supply
voltage output and ground lines are fed into two ferrite beads,
which behave similarly to the common mode choke, to attenuate high
frequency noise signals emitted from the device during use (e.g.,
during charging/connected operation), while supplying low levels of
thermal dissipation and lowering emissions to meet regulatory
performance standards. A first ferrite bead provides a voltage
output from the power supply directly to the power isolation chip
and an isolating device, e.g., a transformer 1103. A flyback switch
of the power isolation chip provides the secondary input to the
transformer 1103 in order to control the switched modes (e.g.,
charging and not charging states) of the infusion device.
[0059] The schematic view of FIG. 11 shows the electrical connector
interface without the overmold. The electrical connector port
opening is protected by the electrical connector port door 1101,
which includes a door plug 1104 that allows the door to remain
fixed to the device during removal and placement over the
electrical connector port. The electrical connector door 1101 also
includes a door insert 1106, which partially fills the electrical
connector port cavity. The door insert 1106, with the o-ring
grooves 820, can form a pressurized seal around the cavity of the
electrical connector port. The electrical connector port door 1101
can be made from a flexible material, such as rubber or soft
polymer, so that repeated removal and placement within the device
do not cause breakage.
[0060] Referring still to FIG. 11, a USB DC-to-DC board 1105 is
also shown. The incoming current from the USB interface is
controlled by a customized transformer 1103. The design of the
transformer 1103 varies from that typically provided within the
art, as the specific size requirements of the portable medical
device and minimum inductance requirements of the USB power
isolation chip impose constraints for the primary and secondary
coils. In some embodiments a 12:9 core turns ratio is utilized
along with at least one triple insulated wire. In a further
embodiment, the transformer 1103 can be a toriod transformer.
However, utilizing the aforementioned embodiments for the
transformer and system design, constrains the low current (100 mA)
loads at which the power isolation chip functions. This is because
the power isolation chip draws less than 100 mA at an input voltage
of 4.4V (low voltage) with a low output load current of SOmA. The
low output load current can then define the high output load
current as 250 mA based on the USB specification current
limitations of five times the low load current.
[0061] The board area illustrated in FIG. 11 can be formed with a
stitched capacitance built into the circuit board, such that EMF
emissions can be further controlled through attenuation of any high
frequency noise provided during use of the infusion device. Each
chip connection is shown including any additional circuitry that is
utilized to power the portable medical device components while
still meeting size and regulatory emission level constraints, such
as IEC 60601-1 Safety Standards.
[0062] FIG. 12 shows a front cross-sectional view of the electrical
connector interface. An electrical connector port 1200 is securely
fit into the housing of the portable medical device through the
first, or outer o-ring 810. That is the-o-ring 810 is located
closer to the outside of the device and is seated in the groove 820
of the USB port door. The inner, or primary o-ring 826 is located
closer to the inner cavity of the device. The o-rings can be made
of rubber or plastic polymer which is impermeable and can securely
be fitted onto the respective locating surfaces 820, 828 (FIG.
8).
[0063] FIG. 12 shows that the overmold 1204 of the power isolation
assembly is coupled to the electrical connector interface assembly.
The coupling is in order to protect the user from experiencing any
electrical shock, or excessive radiation emissions during use of
the portable medical device. The overmold 1204 can extend around,
above and below the electrical connector interface assembly, such
that any current drawn from a power source is isolated in the
portable medical device prior to usage by, e.g., charging the
battery or operating the inner components of the device. The
overmold 1204 can extend across each component of the power
isolation assembly, including the power isolation chip (not shown)
and the transformer 1203. A molded structure 1205 can extend at
least partially around the USC connector to protect the USB
connector during the overmolding process.
[0064] Referring now to FIG. 13, a schematic illustrating the back
view of the portable medical device is shown. The back view of the
device illustrates a back plate 1300, a pumping mechanism 1301, a
cartridge slot 1302, an input button 1304, and a electrical
connector port door 1303. The back of the device is covered by a
back plate 1300, which can be made of a durable plastic polymer or
metal. The back plate 1300 can be semi-permanently attached to the
device, such that removal is only achieved through use of an
instrument or tool in order to protect the inner components of the
portable medical device. The back plate 1300 can cover
substantially all of the back of the portable medical device,
except for a portion of the device which is capable of receiving a
cartridge, such as an insulin cartridge. The back plate 1300 can be
sealed along the outer walls of the portable medical device through
a membrane or other form of sealant, which can prevent water and
other elements (e.g., dust, liquids, etc.) from entering the
device. In some embodiments, the outer walls of the device and the
back plate of the device are formed as a single component. In other
embodiments, the back plate 1300 is one of a plurality of
components which, combined, comprise the housing of the portable
medical device.
[0065] As previously mentioned, the back plate 1300 can exclude a
portion under which an insulin cartridge is received. The cartridge
slot 1302 can include a bump, or ridge 1305 onto which the
cartridge can latch to be aligned in the cartridge slot 1302 to
facilitate placement of the cartridge by a user of the portable
medical device. In some embodiments, the ridge 1305 can instead be
a groove, or ridge into which a cartridge can latch in order to be
properly aligned. It should be understood that numerous variations
to the design of the cartridge slot can be implemented, dependent
on the size and shape of the cartridge. The cartridge of some
embodiments fits securely into the cartridge slot, having minimal
space around the perimeter of the cartridge and between the
cartridge and cartridge slot 1302. The inner wall 1306 of the
cartridge slot 1302 can include a membrane, which forms a
water-tight seal around the cartridge slot 1302 when the cartridge
door 1505 (shown in FIG. 15) is in place. Accordingly, the
cartridge slot 1302 can include a locking mechanism, which allows
the cartridge door to form a pressurized seal with the inner wall
1306 of the cartridge slot 1302.
[0066] Referring now to FIG. 14, a perspective view of the back and
two side walls of the portable medical device is provided. The
portable medical device as shown includes an input button 1401, a
hinge portion of the electrical connector port door 1402, a back
plate 1400, a cartridge slot 1405 for receiving an insulin
cartridge, a ridge 1406 onto which the cartridge is hinged for
alignment into the cartridge slot 1405, a cartridge receiving port
1404, which locks the cartridge into place within the cartridge
slot 1405, and a cartridge slot backplate 1408. FIG. 14 also
illustrates an open view of a pumping mechanism with the back plate
1400 removed. The pumping mechanism includes a rack pushrod 1407
that is utilized to compress the insulin cartridge and cause the
insulin to move to the user through a tube or conduit such as a
cannula (shown in FIG. 1). The pushrod can be made of a metal or
other hard, non-pliable material capable of withstanding extreme
temperatures and contact with liquids. The pushrod 1407
additionally includes a pushrod cover 1403, which is utilized to
form an additional barrier between the pumping mechanism and the
cartridge. The pushrod cover 1403 provides an additional layer of
waterproofing to prevent any insulin leakage from the cartridge
from entering the portable medical device and affecting the inner
components. The pushrod cover 1403 can be made of a pliable plastic
or rubber materials which can sustain repeated compression and
expansion movements and which is impermeable to liquids. In some
embodiments, an o-ring (not shown) can also be placed around the
base of the pushrod 1407 and the top of the pushrod cover 1403 to
prevent leakage into the portable medical device.
[0067] FIG. 15 shows a schematic view of the back of the portable
medical device in FIG. 14 with the rear face removed. As shown in
FIG. 15, the various elements controlled by the PCB on the front
schematic view in FIG. 5 are provided. The device can include a
speaker 1506 for providing alerts and other sounds indicating a
function has been performed on the device. Additionally, the device
can include a micro-valve assembly 1514, including, for example, a
venting system and a thermal leak platform for the insulin
cartridge. The insulin cartridge can be covered by a cartridge door
1505 and the housing of the portable medical device can include a
cartridge shroud 1509 in which the connecting tube or cannula that
delivers the insulin to the patient may be inserted.
[0068] Additionally, the device can include a power charging system
that receives the controlled current from the power isolation chip.
The power charging system may be used to charge a power storage
cell such as a rechargeable battery 1500 of the portable medical
device. Some embodiments may use a rechargeable battery such as a
NiCad battery, LiPo battery, NiMH battery, or the like. The battery
1500 also can be a lithium ion (LiPo) battery or a similar type of
battery known in the art that meets both the size and charge
requirements of the portable medical device.
[0069] The operation for determining charging of the battery 1500
includes various steps which are dependent on the current battery
charge and the current operating mode of the portable device. The
portable medical device can be considered to be in different states
(e.g., active mode, shelf mode) based on the charge level in the
battery and the connection, or lack thereof, to a power supply
source. The portable medical device first determines if a USB power
supply is connected to the device. This determination may occur
through the change in current detected as being supplied to both
the isolated USB data control chip and the isolated USB power
control chip. For example, an "always on" current sensor amplifier
coupled to a Buck regulator can detect the current provided to the
device by the connection to the power source. Two types of
connections can be made to the power source. One is a configurable
combined data/power source (e.g., a computer) and the other is a
dedicated power-only source (e.g., a wall outlet). Depending on the
calculated battery charge level and the mode of the system, each
type of connection can determine a different type of power-up
protocol and can determine how the battery on the device is
charged.
[0070] After determining that a USB power supply has been connected
through the USB interface (behind electrical connector port door
1504), the portable medical device next determines the type of
source device supplying electrical power to the device. If the host
power source is a dedicated power source, the electrical connector
can supply a high mode current to the portable medical device and
charge the battery at a faster rate. Being in a high rate battery
charge does not necessarily signify that the portable medical
device is in high or active mode.
[0071] The load output load current "low mode" charging, also
referred to as suspended state or shelf mode, occurs when the
portable medical device is plugged into a power source such as a
desktop, laptop, or, e.g., tablet computer. That is, a power source
that is not configured for high current connection with the
portable medical device. As noted previously, the computer supplies
only minimal power output (e.g., 100 mA) from the port interfaced
with the power supply until a higher current output "high mode"
(500 mA) can be negotiated, e.g., through configuration of the
power supply. In some cases, if high current charging is requested
before a connection port is configured with the power supply, the
connection port will shut down and no current will be provided to
the portable device.
[0072] The output of the transformer 1103 (shown in FIG. 11)
supplies the aforementioned high mode or low mode current to a
battery charger within the power isolation assembly 1503. The
battery charger can be configured for use with the power supply and
can include a charge current multiplier in order to charge a
battery 1500 coupled to the battery charger even in low mode
conditions. However, in order to supply the minimum amount of power
to charge the battery 1500 and maintain the system components which
inherently draw current and stay "always on," the power stored in
the battery 1500 is monitored as well as the amount of power and
current being supplied to the device during a charge condition,
such as when the power supply is connected to a power supply
source. The control of the power supply based on the current power
within the battery 1500 is performed by a power control processor
(see FIG. 11: 1102), which is coupled to the battery 1500 and
battery charger within the power isolation assembly. The power
control processor can control the power apportioned to the rest of
the system components, such as a pump motor 1511, vibrate 1513,
pump (rack bushing 1501, rack pushrod 1508 and gear box 1507), the
output display screen, peripheral devices (e.g., Bluetooth), the
data processor, and the like.
[0073] A data control processor may send requests to the power
control processor due to an input from the user of the device. For
example, if the user decides to remove and discontinue use of the
device, the user may "power off" the device by depressing the input
button 1502. If the shelf mode request is received by the power
control processor, the power supplied to the data control processor
is discontinued. The data control processor reads instructions
stored in a memory element of the portable medical device for
performing the functions of the components in the device, such as
providing an output display (see FIG. 3: 302), a Bluetooth
transmitter (see FIG. 5: 505), a speaker 1506, a motor 1511
controlling an insulin pump rack pushrod 1508 (e.g., through gears
in gearbox 1508), a touch control chip, and the like.
[0074] Removal of power will not delete data stored in the USB data
isolation chip, nor will power removal eliminate the ability to
charge, power up, or communicate with the data control processor.
The data control processor typically remains in an "always on"
condition, though the power supplied to the components performing
the functions requested by the processor may no longer powered,
such that the functionality of the data control processor is
effectively terminated.
[0075] Referring now to FIGS. 16A-16C, exemplary schematic views of
a waterproof input button 1600 are illustrated. As shown in FIG.
16A, a skeleton view of the outer shell 1601 of the button and the
inner components of the input mechanism 1602 are illustrated. The
housing, or outer shell 1601, of the button 1600 can be made of a
plastic or other polymer in a pre-formed shape and the side walls
can be collapsible such that the input button can be depressed by a
user. The outer shell 1601 can additionally be made of a
non-permeable soft material, such as a dense rubber. The input
mechanism 1602 can be located within a central opening of the outer
shell 1601, such that, when a user erroneously depresses another
area, e.g., side, of the input button, an input is not
received.
[0076] FIG. 16B shows a top view of the input button. The input
button can have a backplate 1603, which sits adjacent to the side
wall of the portable medical device (e.g., element 1304 in FIG.
13). The backplate 1603 can be made of a hard polymer in order to
prevent any voltage leakage from the device during user
interaction. Additionally, the backplate can form a protective
barrier as a portion of the side wall of the housing of the
portable medical device. The backplate can include several soft
ridges or bumps 1604 that can absorb the pressure of the input
button during depression by the user, such that the input mechanism
is not damaged, e.g., due to excessive force during depression, and
such that the top portion of the housing, or outer shell 1601, and
the backplate 1603 do not collide. The bumps 1604 absorb shock and
can be made of a rubber or other force-absorbing non-permeable
material. The bumps 1604 can protrude through pre-formed openings
in the backplate 1603 or can be formed with the backplate 1603 or
on the top plane of the backplate 1603. The input mechanism 1600
can include a spring type assembly, such that when the input button
is depressed, the button returns to its original position.
[0077] FIG. 16C shows a cross-sectional view of the button. The
Input mechanism 1600 extends through the button housing 1601 to a
base point 1606, which provides a contact point to the PCB within
the portable medical device to communicate a signal to wake the
device. The base 1605 of the input button can be formed from a
membrane that is impermeable to water and other liquids. The base
1605 can be formed with the bumps 1604 in order to prevent any
liquid from entering the device. Accordingly, the base 1605 can
cover a portion of the side wall of the portable medical device on
which the input button is located and can form a seal between the
input button housing 1601 of the portable medical device and the
inner components.
[0078] Although the aforementioned description specifically
describes a portable medical device for administering insulin to a
patient, it should be understood that such a device is only one
embodiment of the invention. The device can also include any
portable device having a display and a processor. For example, the
device can include a mobile computing device, such as a Smartphone.
In one embodiment, such a device can be used to remotely control a
portable medical device as described herein. Alternatively, a
portable medical device as described herein may be controlled by a
dedicated remote control specifically designed for use with the
device.
[0079] With regard to the above detailed description, like
reference numerals used therein may refer to like elements that may
have the same or similar dimensions, materials and configurations.
While particular forms of embodiments have been illustrated and
described, it will be apparent that various modifications can be
made without departing from the spirit and scope of the embodiments
herein. Accordingly, it is not intended that the invention be
limited by the forgoing detailed description.
[0080] Modifications may be made to the foregoing embodiments
without departing from the basic aspects of the technology.
Although the technology may have been described in substantial
detail with reference to one or more specific embodiments, changes
may be made to the embodiments specifically disclosed in this
application, yet these modifications and improvements are within
the scope and spirit of the technology. The technology
illustratively described herein suitably may be practiced in the
absence of any element(s) not specifically disclosed herein. Thus,
for example, in each instance herein any of the terms "comprising,"
"consisting essentially of," and "consisting of may be replaced
with either of the other two terms. The terms and expressions which
have been employed are used as terms of description and not of
limitation, and use of such terms and expressions do not exclude
any equivalents of the features shown and described or portions
thereof, and various modifications are possible within the scope of
the technology claimed. The term "a" or "an" may refer to one of or
a plurality of the elements it modifies (e.g., "a reagent" can mean
one or more reagents) unless it is contextually clear either one of
the elements or more than one of the elements is described.
Although the present technology has been specifically disclosed by
representative embodiments and optional features, modification and
variation of the concepts herein disclosed may be made, and such
modifications and variations may be considered within the scope of
this technology.
* * * * *